Study to Test Shorter Duration Chemoradiation Therapy Versus Standard Duration Chemoradiation Therapy for Cervical Cancer

Trial details

Who runs it

NRG Oncology

Trial code

NCT07928466

Record updated

2026. november 10.

Original description

This phase III trial compares the effect of a shorter duration (hypofractionated) of intensity-modulated radiation therapy (IMRT) with brachytherapy and cisplatin to standard duration IMRT with brachytherapy and cisplatin in treating patients with newly diagnosed stage IB2-IIIC1 cervical cancer. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. IMRT is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. A radiation boost is extra radiation to the area where the tumor is located which increases the amount of radiation given to the tumor bed. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving hypofractionated chemoradiation therapy may be as safe, tolerable and/or effective as the standard, longer course of chemoradiation therapy in treating patients newly diagnosed with stage IB2-IIIC1 cervical cancer.Read full original descriptionShow less

A Phase III Non-Inferiority Trial of Hypofractionated Chemoradiation Therapy Versus Standard Chemoradiation for Cervical Cancer

This phase III trial compares the effect of a shorter duration (hypofractionated) of intensity-modulated radiation therapy (IMRT) with brachytherapy and cisplatin to standard duration IMRT with brachytherapy and cisplatin in treating patients with newly diagnosed stage IB2-IIIC1 cervical cancer. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. IMRT is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. A radiation boost is extra radiation to the area where the tumor is located which increases the amount of radiation given to the tumor bed. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving hypofractionated chemoradiation therapy may be as safe, tolerable and/or effective as the standard, longer course of chemoradiation therapy in treating patients newly diagnosed with stage IB2-IIIC1 cervical cancer.

Inclusion: Patients must have histologically confirmed newly diagnosed cervical cancer. Eligible pathologic types: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma; Patients must have a diagnosis of Federation of Gynecology and Obstetrics (FIGO) 2018 stage IB2 (T1B2, N0), stage IB3 (T1B3N0), II (T2A-B, N0), IIIC1 (T1B2-3, N1), or IIIC1 (T2A-B, N1) squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix not amenable to curative surgical resection alone; Negative for para-aortic disease AND treating physician does not plan to treat para-aortic nodes; Radiologic definition of lymph node staging:; N1:; One or more pelvic lymph nodes with short axis diameter of ≥ 15 mm (axial plane) by CT or MRI, and/or; One or more pelvic lymph nodes with short axis diameter of ≥ 10 mm and standarized uptake value maximum (SUVmax) ≥ 2.5 by fludeoxyglucose F-18 (FDG)-PET; No prior definitive surgical, radiation, or systemic therapy for cervical cancer. Induction chemotherapy with weekly carboplatin (area under curve [AUC]2) and paclitaxel (80 mg/m\^2) for up to 6 weeks is allowed prior to study entry. This is the only permissible induction chemotherapy regimen prior to study entry; No prior or concurrent immunotherapy; No prior pelvic radiation therapy; Age ≥/= 18; Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; Not pregnant and not nursing; Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3; Platelets ≥ 100,000 cells/mm\^3; Hemoglobin ≥ 8 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] ≥ 8 g/dl is acceptable); Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula; Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN; Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II B or better; No active infection requiring parenteral antibiotics; No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube; No history of allergic reaction to cisplatin or compounds of similar chemical or biologic composition.

ClinicalTrials.gov NCT07928466